Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain

NCT07562412 | Not Yet Recruiting

• 1 other identifier: STUDY00004916_Dose
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.

Conditions

Pain; Pain Management; Orthopedic; Acute Pain; Chronic Pain; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in Pain Unpleasantness Numeric Rating Scale

  Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.

  Immediately before to after the 1- to 3-minute audio recording

Secondary Outcomes (1)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before to after the 1- to 3-minute audio recording

Study Arms (3)

1-Minute Mindfulness Intervention

ACTIVE COMPARATOR

Behavioral: 1-Minute Mindfulness Intervention

2-Minute Mindfulness Intervention

ACTIVE COMPARATOR

Behavioral: 2-Minute Mindfulness Intervention

3-Minute Mindfulness Intervention

EXPERIMENTAL

Behavioral: 3-Minute Mindfulness Intervention

Interventions

1-Minute Mindfulness Intervention BEHAVIORAL

Participants listen to a 1-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.

1-Minute Mindfulness Intervention

2-Minute Mindfulness Intervention BEHAVIORAL

Participants listen to a 2-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.

2-Minute Mindfulness Intervention

3-Minute Mindfulness Intervention BEHAVIORAL

Participants listen to a 3-minute audio recording delivering a brief, guided mindfulness exercise focused on breath awareness. The intervention instructs participants to attend to the sensations of inhalation and exhalation, use simple mental labels (e.g., "in," "out"), and gently return attention to the breath when distracted. Participants are also encouraged to notice discomfort without attempting to change it.

3-Minute Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving treatment at Tallahassee Orthopedic Center
• Understanding English instructions fluently
• Being 18 years of age or older

You may not qualify if:

• Unable to consent because of physical or mental incapacity.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Tallahassee Orthopedic Clinic

Tallahassee, Florida, 32310, United States

Location

MeSH Terms

Conditions

Pain; Agnosia; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Adam Hanley

CONTACT

850-645-9557; adam.hanley@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)